The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Experimental: Formulation 2

Biological: Pneumococcal vaccine GSK2189241A

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Experimental: Formulation 6

Biological: Pneumococcal vaccine GSK2189241A

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Experimental: Formulation 1

Biological: Pneumococcal vaccine GSK2189241A

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Active Comparator: 23 valent pneumococcal vaccine

Biological: Pneumo 23™

One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.

Experimental: Formulation 3

Biological: Pneumococcal vaccine GSK2189241A

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Experimental: Formulation 4

Biological: Pneumococcal vaccine GSK2189241A

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Eligibility

Ages Eligible for Study:

65 Years to 85 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.

Male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health.

Written informed consent obtained from the subject.

Exclusion Criteria:

Previous vaccination against Streptococcus pneumoniae (with a licensed vaccine or with an investigational candidate vaccine).

Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered at least 7 days preceding or at least 7 days following any vaccine dose.

Administration of immunoglobulins and/or any blood products within the last 3 months.

Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests at the discretion of the investigator.

Laboratory evidence of haematological abnormalities.

Laboratory evidence of biochemical abnormalities.

History of chronic alcohol consumption and/or drug abuse.

Other conditions that the principal investigator judges may interfere with study findings.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756067